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Completed

NCT Number: NCT02002832

A Clinical Trial of Lurasidone in Treatment of Schizophrenia

This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Huilongguan Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written informed consent and aged between 18 and 65 years of age.
  • Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
  • Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
  • Able and agrees to remain off prior antipsychotic medication for the duration of study.
  • Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion criteria

  • Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
  • Any chronic organic disease of the CNS(other than schizophrenia)
  • Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
  • Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Treatment and study plan

Lurasidone tablets

Drug

Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)

Other names: LATUDA

Risperidone tablets

Drug

Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

Primary outcomes

  1. Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.

    Time frame: From baseline to Week 6(day 42).

    Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.

Secondary outcomes

  1. Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.

    Time frame: From baseline to Week 6(day 42).

    The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:

    1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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